U.S. patent number 6,652,565 [Application Number 09/939,238] was granted by the patent office on 2003-11-25 for central venous catheter with heat exchange properties.
This patent grant is currently assigned to Alsius Corporation. Invention is credited to Scott M. Evans, Xia Luo, Robert Pecor, Lynn M. Shimada, Blair D. Walker, William J. Worthen.
United States Patent |
6,652,565 |
Shimada , et al. |
November 25, 2003 |
Central venous catheter with heat exchange properties
Abstract
An introducer sheath for a central venous catheter includes a
sheath body and a temperature sensor mounted distally on the body.
Either the catheter or sheath has a heat exchange region through
which coolant is circulated to effect heat exchange with the body,
with the coolant temperature being controlled in response to
signals from the temperature sensor. Arterial dialysis heat
exchange catheters and jugular bulb heat exchange catheters are
also disclosed.
Inventors: |
Shimada; Lynn M. (Orange,
CA), Worthen; William J. (Coto de Caza, CA), Evans; Scott
M. (Santa Ana, CA), Luo; Xia (Los Angeles, CA),
Pecor; Robert (Aliso Viejo, CA), Walker; Blair D.
(Mission Viejo, CA) |
Assignee: |
Alsius Corporation (Irvine,
CA)
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Family
ID: |
23485361 |
Appl.
No.: |
09/939,238 |
Filed: |
August 24, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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376524 |
Aug 18, 1999 |
6419643 |
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253109 |
Feb 19, 1999 |
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376524 |
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376524 |
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305613 |
May 5, 1999 |
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063984 |
Apr 21, 1998 |
6126684 |
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Current U.S.
Class: |
607/105; 607/104;
607/106 |
Current CPC
Class: |
A61B
17/3415 (20130101); A61F 7/12 (20130101); A61F
7/123 (20130101); A61M 25/00 (20130101); A61M
25/0662 (20130101); A61B 17/3417 (20130101); A61B
17/3421 (20130101); A61B 17/3462 (20130101); A61B
2017/00084 (20130101); A61B 2018/00011 (20130101); A61B
2018/00023 (20130101); A61F 7/10 (20130101); A61F
2007/126 (20130101); A61M 1/369 (20130101); A61M
5/44 (20130101); A61M 25/0028 (20130101); A61M
25/0032 (20130101); A61M 25/1011 (20130101); A61M
2025/0031 (20130101); A61M 2025/0036 (20130101); A61M
2025/1013 (20130101); A61M 2205/36 (20130101) |
Current International
Class: |
A61B
17/34 (20060101); A61F 7/12 (20060101); A61M
25/00 (20060101); A61M 25/06 (20060101); A61B
18/00 (20060101); A61F 7/10 (20060101); A61F
7/00 (20060101); A61B 17/00 (20060101); A61M
1/36 (20060101); A61M 25/10 (20060101); A61M
5/44 (20060101); A61F 007/00 () |
Field of
Search: |
;607/96,104-107,112
;606/20-23,27-28 ;600/309,323 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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0 524 662 |
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Jan 1993 |
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EP |
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0 853 951 |
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Jul 1998 |
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EP |
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WO 91/05528 |
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May 1991 |
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WO |
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WO 98/31312 |
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Apr 1998 |
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WO |
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WO 98/26831 |
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Jun 1998 |
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WO |
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Other References
US. patent application Ser. No. 09/253,109, Evans et al., filed
Feb. 19, 1999. .
U.S. patent application Ser. No. 09/305,613, Aliberto et al., filed
May 5, 1999. .
U.S. patent application Ser. No. 09/376,524, Shimada et al., filed
Aug. 18, 1999..
|
Primary Examiner: Gibson; Roy D.
Attorney, Agent or Firm: Rogitz; John L.
Parent Case Text
This application is a divisional of U.S. patent application No.
09/376,524 entitled "Central Venous Catheter with Heat Exchange
Properties", filed on Aug. 18, 1999 now U.S. Pat. No. 6,419,643,
which is a CIP of co-pending U.S. patent application Ser. No.
09/253,109 entitled "Central Venous Line Catheter Having
Temperature Control System", filed Feb. 19, 1999, The parent
application Ser. No. 09/376,524 is also a CIP of co-pending U.S.
patent application Ser. No. 09/305,613 entitled "Central Venous
Catheter With Heat Exchange Membrane", filed May 5, 1999, and is a
CIP of U.S. patent application Ser. No. 09/063,984, filed Apr. 21,
1998, now issued as U.S. Pat. No. 6,126,684 entitled "Indwelling
Heat Exchange Catheter and Method of Using Same", all of which are
incorporated herein by reference.
Claims
What is claimed is:
1. A jugular vein catheter system, comprising: a catheter body
bearing at least one oxygen sensor; an optical fiber connected to
the oxygen sensor; an oxygen measuring system connected to the
fiber; a heat exchange region associated with a distal segment of
the catheter body, wherein the body is formed with a coolant supply
lumen and a coolant return lumen, both of the lumens communicating
with the heat exchange region to effect heat exchange with a
patient's body.
2. The system of claim 1, wherein the heat exchange region is
established by at least one membrane attached to the body.
3. A jugular vein catheter system, comprising: a catheter body
bearing at least one oxygen sensor; an optical fiber connected to
the oxygen sensor; an oxygen measuring system connected to the
fiber; a heat exchange region associated with a distal segment of
the catheter body, further comprising at least one sensor selected
from the group including: temperature sensors, pressure sensors,
the sensor being supported by the body and operably connected
through at least one sensor lumen with a monitoring system.
4. An arterial catheter system, comprising: a catheter body bearing
at least one blood lumen; a dialysis system communicating with the
blood lumen; a heat exchange region associated with a distal
segment of the catheter body, wherein the body is formed with a
coolant supply lumen and a coolant return lumen, both of the lumens
communicating with the heat exchange region to effect heat exchange
with a patient's body.
5. The system of claim 4, wherein the heat exchange region is
established by at least one membrane attached to the body.
6. A heat exchange catheter, comprising: a catheter body defining
at least a coolant supply lumen, a coolant return lumen, and an air
lumen; at least a first cooling membrane defining a chamber
communicating with the coolant supply and return lumens; and at
least a first inflation balloon disposed in the chamber and
selectively movable between an inflated configuration, wherein the
inflation balloon causes coolant to flow near an outer surface of
the cooling membrane to thereby effect relatively greater heat
exchange with the blood, and a deflated configuration, wherein
coolant tends to flow through the cooling membrane with a laminar
flow characteristic nearer the catheter body than the outer surface
of the cooling membrane.
7. A central venous access system, comprising: a multi-lumen
catheter; at least one of: a heat exchange membrane, and a balloon,
located distally on the catheter and communicating with at least
one coolant lumen of the catheter; a heat exchange system
communicating with at least the coolant lumen, coolant being
circulatable between the heat exchange system and the membrane or
balloon to effect heat exchange with a patient; and wherein at
least one lumen of the catheter is adapted to engage a central
venous component, the central venous component being at least one
of: a source of medicament, a syringe, a device, and a sensing
system.
Description
FIELD OF THE INVENTION
The present invention relates generally to methods and apparatus
for cooling patients for therapeutic purposes, and more
particularly to systems for establishing central venous access
while providing a means for cooling a patient.
BACKGROUND
It has been discovered that the medical outcome for a patient
suffering from severe brain trauma or from ischemia caused by
stroke or heart attack is degraded if the patient's body
temperature rises above normal (38.degree. C.). It is further
believed that the medical outcome for many such patients might be
significantly improved if the patients were to be cooled relatively
quickly for a short period, e.g., 24-72 hours. Apart from the
therapeutic benefits of hypothermia, the outcomes for brain trauma
or ischemia patients that develop fevers is worse than for patients
that do not develop fevers. Consequently, temperature management
for such patients is important, even when hypothermia is not to be
used to treat the patients. Moreover, prophylactic short-term
hypothermia might help patients undergoing minimally invasive heart
surgery and aneurysm surgery.
The affected organ, in any case, is the brain. Accordingly, systems
and methods have been disclosed that propose cooling blood flowing
to the brain through the carotid artery. An example of such systems
and methods is disclosed in co-pending U.S. pat. app. Ser. No.
09/063,984, filed Apr. 21, 1998, owned by the present assignee and
incorporated herein by reference. In the referenced application,
various catheters are disclosed which can be advanced into a
patient's carotid artery and through which coolant can be pumped in
a closed circuit, to remove heat from the blood in the carotid
artery and thereby cool the brain. The referenced devices have the
advantage over other methods of cooling (e.g., wrapping patients in
cold blankets) of being controllable, relatively easy to use, and
of being capable of rapidly cooling and maintaining blood
temperature at a desired set point.
As recognized in co-pending U.S. pat. app. Ser. No. 09/133,813,
filed Aug. 13, 1998, owned by the present assignee and incorporated
herein by reference, the above-mentioned advantages in treating
brain trauma/ischemic patients by cooling can also be realized by
cooling the patient's entire body, i.e., by inducing systemic
hypothermia. The advantage of systemic hypothermia is that, as
recognized by the present assignee, to induce systemic hypothermia
a cooling catheter or other cooling device need not be advanced
into the blood supply of the brain, but rather can be easily and
quickly placed into the relatively large vena cava of the central
venous system.
Moreover, since many patients already are intubated with central
venous catheters for other clinically approved purposes anyway,
providing a central venous catheter that can also cool the blood,
if only to manage temperature and thereby ameliorate fever spikes,
requires no additional surgical procedures for those patients. A
cooling central venous catheter is disclosed in the present
assignee's co-pending U.S. patent application Ser. No. 09/253,109,
filed Feb. 19, 1999 and incorporated herein by reference. The
present inventions are directed to central venous cooling
devices.
SUMMARY OF THE INVENTION
An introducer sheath for a central venous line catheter includes a
hollow body defining a proximal end, a distal end positionable in a
patient, and at least one catheter placement lumen extending
therebetween. A barrier such as a septum or hemostasis valve is in
the lumen at or near the proximal end of the body for selectively
blocking the lumen, and at least one temperature sensor such as a
thermistor or thermocouple is mounted on the body at or near the
distal end for generating a temperature signal. The catheter can
include at least one distally-located cooling membrane.
If desired, the body of the sheath further includes a coolant
supply lumen and a coolant return lumen. Both the coolant supply
lumen and coolant return lumen communicate with a distally-located
heat transfer region associated with the body. The heat transfer
region can be established by at least one membrane that is attached
to the body, or by at least one distally-located fluid passageway
that is formed in the body.
In another aspect, an introducer sheath for a central venous line
catheter includes a hollow body defining a proximal end, a distal
end positionable in a patient, and at least one catheter placement
lumen extending therebetween. The body also defines a coolant
supply lumen and a coolant return lumen. A barrier is disposed in
the catheter placement lumen at or near the proximal end of the
body for selectively blocking the catheter placement lumen, and a
distally-located heat transfer region is associated with the body
in communication with the coolant supply and return lumens.
In yet another aspect, a jugular vein catheter system includes a
catheter body bearing at least one oxygen sensor connected to an
optical fiber. An oxygen measuring system is connected to the
fiber, and a heat exchange region is associated with a distal
segment of the catheter body.
In still another aspect, an arterial catheter system includes a
catheter body bearing at least one blood lumen, and a dialysis
system communicating with the blood lumen. A heat exchange region
is associated with a distal segment of the catheter body.
In another aspect, a heat exchange catheter includes a catheter
body defining at least a coolant supply lumen, a coolant return
lumen, and an air lumen. A cooling membrane defines a chamber that
communicates with the coolant supply and return lumens, and an
inflation balloon is disposed in the chamber. The inflation balloon
is selectively movable between an inflated configuration, wherein
the inflation balloon causes coolant to flow near an outer surface
of the cooling membrane to thereby effect relatively greater heat
exchange with the blood, and a deflated configuration, wherein
coolant tends to flow through the cooling membrane with a laminar
flow characteristic nearer the catheter body than the outer surface
of the cooling membrane.
In still another aspect, a central venous access system includes a
multi-lumen catheter, at least one heat exchange membrane or
balloon located distally on the catheter and communicating with at
least one coolant lumen of the catheter, and a heat exchange system
communicating with at least the coolant lumen. Coolant is
circulated between the heat exchange system and the membrane or
balloon to effect heat exchange with a patient. At least one holder
is engageable with the catheter to hold the catheter onto a
patient. Also, a central venous system communicates with at least
one lumen of the catheter.
The present invention also discloses an improvement to a Foley
catheter configured for placement in the urinary tract of a
patient. The improvement includes at least one heat exchange
membrane or balloon located distally on the catheter body and
communicating with at least one coolant lumen of the catheter. A
heat exchange system communicates with at least the coolant lumen,
with coolant being circulated between the heat exchange system and
the membrane or balloon to effect heat exchange with a patient.
Moreover, a method is disclosed for heat exchange with a patient.
The method includes advancing a catheter into the urinary tract of
a patient, and circulating saline through the catheter in a closed
loop to exchange heat with the patient.
The details of the present invention, both as to its structure and
operation, can best be understood in reference to the accompanying
drawings, in which like reference numerals refer to like parts, and
in which:
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is an exploded perspective view of a first embodiment of an
entry sheath for a venous catheter, schematically showing a cooling
system in communication with the catheter;
FIG. 1A is a longitudinal cross-section as would be seen along the
line 1A--1A in FIG. 1, of an alternate balloon configuration for
the catheter shown in FIG. 1;
FIG. 2 is a perspective view of a second embodiment of the entry
sheath, configured for providing cooling capability in a patient's
central venous system;
FIG. 3 is a cross-sectional view as seen along the line 3--3 in
FIG. 2;
FIG. 3A is a cross-sectional view of an alternate sheath that
includes a distal cooling balloon, as would be seen along the line
3--3 in FIG. 2;
FIG. 4 is a perspective view of a so-called jugular bulb catheter
configured for cooling a patient, schematically showing various
jugular bulb components and a cooling system connected to the
catheter;
FIG. 5 is a cross-sectional view as seen along the line 5--5 in
FIG. 4;
FIG. 6 is a perspective view of a dialysis catheter configured for
cooling a patient, schematically showing various dialysis
components and a cooling system connected to the catheter;
FIG. 7 is a cross-sectional view as seen along the line 7--7 in
FIG. 6;
FIG. 8 is a perspective view of a Foley catheter configured for
cooling a patient, schematically showing various Foley catheter
components and a cooling system connected to the catheter; and
FIG. 9 is a cross-sectional view as seen along the line 9--9 in
FIG. 8.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring initially to FIG. 1, a therapeutic catheter system,
generally designated 10, is shown for establishing and maintaining
hypothermia in a patient, or for attenuating a fever spike in a
patient and then maintaining normal body temperature in the
patient, or for returning a hypothermic patient to normothermic.
Commencing the description of the system 10 at the proximal end, as
shown the system 10 includes a cooling system 12 that can be a
water-bath system or a TEC-based system such as either of the
systems disclosed in co-pending U.S. patent application Ser. No.
09/220,897, filed Dec. 24, 1998 and incorporated herein by
reference, or U.S. patent application Ser. No. 09/260,950, filed
Mar. 2, 1999, also incorporated herein by reference. In any case,
the coolant system 12 provides coolant such as saline water through
a coolant supply line 14, and coolant is returned to the source 12
via a coolant return line 16. A catheter, generally designated 18,
includes respective coolant supply and return lumens that
communicate with the lines 14, 16 to establish a closed circuit
coolant path between the catheter 18 and coolant source 12.
In one preferred embodiment, the catheter 18 is any one of the
catheters disclosed in the above-referenced priority applications,
incorporated herein by reference. For example, the catheter 18 can
be the catheter disclosed in U.S. patent application Ser. No.
09/253,109, filed Feb. 19, 1999, which catheter includes a holder
18a to hold the catheter onto a patient for long-term intubation.
The above-referenced application discloses an exemplary anchor that
can establish the holder 18a. In addition to the structure
disclosed in the above-referenced application, the in-growth flange
set forth in U.S. Pat. No. 4,578,063 can be used as the present
holder, or the anchoring systems set forth in U.S. Pat. Nos.
5,693,032 or 5,192,274 can be used, or the anchoring tape set forth
in U.S. Pat. No. 3,677,250 can be used, or suture thread can be
wound around the catheter body and attached to the patient to
establish the holder. All of the above-referenced patents are
incorporated herein by reference. Also, one or more central venous
systems 19 communicate with one or more lumens of the catheter 18
via respective tubes 19a (only a single system 19 shown for
clarity). The central venous system 19 can be, e.g., a source of
medicament to be infused into a patient's central venous system, or
a syringe or other device for extracting central venous blood from
a patient, or a pressure monitoring or blood gas monitoring or
temperature monitoring system.
Alternatively, the catheter 18 can be the modified catheter 20
shown in FIG. 1 A, which in all essential respects is identical to
the two-balloon catheter set forth in U.S. patent application Ser.
No. 09/305,613, filed May 5, 1999, with the following
exceptions.
As shown in FIG. 1A, each of the two cooling balloons (only a
single cooling balloon 22 is shown for clarity of disclosure) of
the catheter 20 surrounds a respective inflation balloon 24.
Coolant from a cooling system 26 or other coolant source enters
each cooling balloon 22 through a coolant supply lumen 28 and
coolant supply port or ports 30 and exits the cooling balloon 22
through a coolant exit port or ports 32 and coolant return lumen
34.
Additionally, inflation fluid such as air can be directed into the
inflation balloon 24 from an air source 36 through an inflation
lumen 38 and air port or ports 40 to inflate the inflation balloon
24. Air can be exhausted from the inflation balloon 24 back though
the inflation lumen 38 to collapse the inflation balloon 24. With
this structure, the inflation balloon 24 can be selectively moved
between an inflated configuration (shown), wherein the inflation
balloon 24 causes coolant to flow near the outer surface of the
respective cooling balloon 22 and thereby effect relatively greater
heat exchange with the blood, and a deflated configuration, wherein
coolant tends to flow through the cooling balloon 22 with a laminar
flow characteristic nearer the body of the catheter 20 than the
outer surface of the catheter.
Referring back to FIG. 1, the catheter 18 can be introduced into a
patient through an elongated hollow plastic introducer sheath 42
having a hollow body 42A and a side port 43 connected to the body
42A. The sheath 42 preferably is coated with an anti-microbial
agent, and it can also be coated with an anti-clotting substance
such as heparin.
As shown, the sheath 42 includes a proximal end 44 and an open
distal end 46, it being understood that a working lumen through
which the catheter 18 (or other catheter, conventional or
otherwise) can be advanced extends between the proximal end 44 and
distal end 46 of the sheath 42. A barrier 48 such as a septum or
hemostasis valve or other barrier selectively blocks the working
lumen. The catheter 18 can be advanced through the barrier 48, with
the barrier 48 sealing against the catheter 18. Upon removal of the
catheter 18, the barrier 48 closes to prevent backflow through the
working lumen out of the proximal end 44 of the sheath 42.
In the preferred embodiment shown, a temperature sensor 50 is
mounted on the sheath 42 at or near the distal end 46 to sense the
temperature of blood flowing past the distal end 46. The sensor 50
can be a thermistor or thermocouple or other suitable temperature
sensing device. In any case, the sensor 50 is operably connected to
the cooling system 12 as schematically indicated by the dashed line
52, to provide temperature feedback to the system 12. This
connection can be made by wireless transmission or through a wire
or fiber that extends through the wall of the sheath 42. The sensor
50 can be mounted on the sheath 42 by solvent bonding or disposed
in a lumen of the sheath 42, or attached to a wire that is disposed
in a lumen of the sheath 42, with the sensor hanging outside the
sheath 42.
FIG. 2 shows that instead of a cooling catheter 18, 20, a
non-cooling catheter 54 such as a conventional central venous
catheter or a Swan-Ganz catheter as exemplified in U.S. Pat. No.
3,995,623 can be provided. In this case, a sheath 56 which is in
all essential respects identical to the sheath 42 shown in FIG. 1,
with the following exceptions, can be provided. The sheath 56
includes a central working lumen 58 (FIG. 3) for receiving the
catheter 54 therein in slidable engagement, and at least along a
distal segment of the sheath 56 coolant supply and return lumens
60, 62 surround the working lumen 58 to establish a
distally-located heat transfer region. Accordingly, in the
embodiment shown in FIGS. 2 and 3 a heat transfer region is
established by at least one distally-located fluid passageway
(e.g., either or both of the lumens 60, 62) that is formed in the
body 66 of the sheath 56.
As shown best in FIG. 3, the working lumen 58 is defined by a
central lumen wall 64, with the supply and return lumens 60, 62
being established between the wall 64 and an outer wall 66 of the
sheath 56. Separator ribs 68, 70 extend laterally between the walls
64, 66 along the length of the coolant supply and return lumens 64,
66 to separate the coolant supply and return lumens 60, 62.
In accordance with the present invention, the coolant supply and
return lumens 60, 62 communicate, via a side port 72 having supply
and return tubes 74, 76, with a cooling system 78 that is in all
essential respects identical to the system 12 shown in FIG. 1. If
desired, a temperature sensor 80 can be mounted on the sheath 56 to
provide temperature feedback to the cooling system 78 in accordance
with principles set forth above.
Alternatively, as shown in FIG. 3A a thin-walled cooling balloon or
membrane 82 can surround a distal segment of the outer wall 66 of
the sheath 56, to establish a cooling chamber 84 between the outer
wall 66 and the balloon or membrane 82. The embodiment of the
sheath 56 shown in FIG. 3A would then function essentially
analogously to the cooling catheters disclosed in the
above-referenced patent applications, with the coolant from the
system 78 entering and exiting the chamber 84 through respective
coolant supply and return passageways in the sheath 56. In the
embodiment shown in FIG. 3A, the distally-located heat transfer
region is established by the balloon or membrane 82.
Now referring to FIGS. 4 and 5, a jugular vein catheter system,
generally designated 100, includes a jugular catheter body 102
bearing an oxygen sensor, shown schematically at 104. The jugular
catheter can be the fiberoptic intravascular catheter sold under
the trademark "Opticath" by Abbot Critical Care Systems, or a
jugular catheter made by Baxter International, with the exceptions
noted below.
An optical fiber 106 is connected to the oxygen sensor 104, and the
fiber 106 terminates in an optical connection 108. In turn, the
connector 108 can be connected to an oxygen measuring system 110.
Further, a temperature sensor, shown schematically at 112, is
supported by the body and is operably connected through a sensor
lumen 113 (FIG. 5) with a monitoring system 114. Both the oxygen
and temperature sensor connecting lines can extend through the
sensor lumen 113. Moreover, a pressure sensor, shown schematically
at 116, is supported on the body 102, and the pressure sensor 116
communicates via a pressure/infusion lumen 118 and luer-like
filling 120 with a pressure sensing system 122 or with a drug
infusion device 124, such as a syringe or IV bag.
Unlike conventional jugular bulb catheters, however, the catheter
102 shown in FIGS. 4 and 5 includes a distally-located balloon or
membrane 126. The balloon or membrane 126 is attached to the
catheter body and communicates with coolant supply and return
lumens 128,130 that are formed in the catheter body. In turn, the
coolant lumens 128, 130 communicate via coolant supply and return
lines 132,134 with a cooling system 136. With this structure,
coolant can be circulated in the balloon or membrane 126 to effect
heat exchange with a patient's body.
In addition to the above heat exchange structures, an arterial
catheter system, generally designated 150 in FIGS. 6 and 7, can be
provided to effect heat exchange with a patient. The system 150
includes an arterial catheter body 152. In accordance with arterial
catheter principles, the body 152 includes a blood supply lumen 154
and a blood return lumen 156, both of which communicate with a
dialysis blood source 158 via blood supply and return tubes 160,162
for undertaking dialysis of a patient's blood.
As intended by the present invention, the arterial catheter system
150 also includes a heat exchange region associated with a distal
segment of the catheter body 152. The body 152 includes coolant
supply and return lumens 164,166 that communicate with a cooling
system 168 via supply and return tubes 170,172, with the lumens
164, 166 establishing the heat exchange region. Or, the heat
exchange region can be established by at least one distally-located
balloon or membrane 174 that communicates with the supply and
return lumens 166, 168 in accordance with present principles.
FIGS. 8 and 9 show a Foley catheter, generally designated 200, that
is adapted for use for cooling the interior of a patient's bladder,
to effect patient cooling. As shown, the catheter 200 includes a
flexible resilient catheter body 202 terminating in a central fluid
drainage tube 204 that communicates with a urine drainage lumen 206
(FIG. 9) in the body 202. The drainage tube 204 can be connected to
a fluid collection receptacle 208 in accordance with Foley catheter
principles known in the art. Also, the body 202 terminates in a
temperature connector tube 210, and a temperature lead 212 extends
through the connector tube 210 and a temperature lead lumen 214
(FIG. 9) for connecting a temperature sensor 216 that is distally
located on the body 202 with a temperature monitor system 218.
Moreover, a drug infusion tube 220 can be connected to a drug
infusion source 222 to infuse drugs into the bladder of a patient
through the drug infusion tube 220 and a drug infusion lumen 224
that communicates with the drug infusion tube 220.
In addition to the conventional Foley catheter structure described
above, the catheter 200 shown in FIGS. 8 and 9 includes coolant
supply and return lumens 226, 228 that communicate with at least
one balloon or membrane 230 that is distally located on the
catheter body 202 in accordance with principles set forth above.
Coolant such as saline from a cooling system 232 is circulated
through coolant supply and return lines 234, 236, coolant lumens
226, 228, and balloon or membrane 230 in a closed loop to remove
heat from a bladder of a patient into which the catheter 200 has
been advanced. It is to be understood that while FIG. 9 illustrates
one lumen design layout, other layouts can be used. It is to be
further understood that the cooling system 232 is in all essential
respects identical in operation and construction to the
above-described cooling systems. If desired, the temperature
monitor system 218 can be connected to the cooling system 232 as
indicated at the line 236 to provide temperature feedback to the
cooling system 232.
While the particular CENTRAL VENOUS CATHETER WITH HEAT EXCHANGE
MEMBRANE as herein shown and described in detail is fully capable
of attaining the above-described objects of the invention, it is to
be understood that it is the presently preferred embodiment of the
present invention and is thus representative of the subject matter
which is broadly contemplated by the present invention, that the
scope of the present invention fully encompasses other embodiments
which may become obvious to those skilled in the art, and that the
scope of the present invention is accordingly to be limited by
nothing other than the appended claims, in which reference to an
element in the singular is not intended to mean "one and only one"
unless explicitly so stated, but rather "one or more". All
structural and functional equivalents to the elements of the
above-described preferred embodiment that are known or later come
to be known to those of ordinary skill in the art are expressly
incorporated herein by reference and are intended to be encompassed
by the present claims. Moreover, it is not necessary for a device
or method to address each and every problem sought to be solved by
the present invention, for it to be encompassed by the present
claims. Furthermore, no element, component, or method step in the
present disclosure is intended to be dedicated to the public
regardless of whether the element, component, or method step is
explicitly recited in the claims. No claim element herein is to be
construed under the provisions of 35 U.S.C. 112, sixth paragraph,
unless the element is expressly recited using the phrase "means
for".
* * * * *